Comparison of Two Biodegradable Polymer Coated, Drug-Eluting Coronary Stents Paclitaxel vs. Sirolimus, with 6-Years Clinical Follow-Up: BIOPRESS (BIOdegradable Polymer REgistry Smt Stents) Infinnium vs. Supralimus

Abstract

Background : The safety and efficacy of drug-eluting stents has been shown in randomized trials, but some controversy exists regarding which stent, sirolimus-eluting or paclitaxel-eluting is more effective in unselected real-world patients. Therefore, we investigated, long term safety and efficacy of paclitaxel-eluting stents (PES) compared to sirolimus-eluting stents (SES) when used without restriction in unselected real-world patients. Methods : We created a prospective, open label, non-randomized, multicenter registry and analyzed data on a consecutive series of all patients who presented to our institution with symptomatic coronary artery disease between July-2004 and June-2006 and who were treated with the Infinnium ® PES or the Supralimus ® SES. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained up to 6-years clinical outcomes including death, myocardial infarction (MI), stent thrombosis (ST), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of cardiac death, TLR, TVR and ST). Results : In total, 571 patients were treated with either the Infinnium ® PES (n=276) or the Supralimus ® SES (n=295). Baseline clinical and angiographic characteristics were almost similar in the two groups. The six-year clinical follow-up was completed in 529 patients (92.6%). Total 1.4% in-hospital major adverse cardiac event (MACE) were recorded (1.8% Infinnium ® PES vs. 1.0% Supralimus ® SES) with 99% procedural success. At 6-years, all-cause death was significantly lower in Supralimus ® SES group than in Infinnium ® PES group (3.1% vs. 6.9%, p =0.03). The incidence of cardiac death (4.3% vs. 2.7%, p =0.29), TLR (3.6% vs. 3.7%, p =0.95, TVR (4.0% vs. 2.4%, p =0.27) and ST (2.5 vs. 1.0, p =0.17) was more frequent in the Infinnium ® PES group compare to Supralimus ® SES group, but it did not reach statistical significance. Conclusion : The long-term follow-up of 6-years, demonstrated the safety and efficacy of both Infinnium ® PES and Supralimus ® SES biodegradable polymer coated drug-eluting stents (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world practice. Also superiority of Supralimus ® SES proved on long term follow-up with complex lesions.